Ensuring Smooth Submission of Inclusion Data


NIH requires participant-level data in progress reports for all clinical research that come in on applications for due dates January 25, 2019 or later (see our Inclusion Across the Lifespan policy).  Grantees use the Inclusion Enrollment report template provided through NIH’s Human Subjects System (HSS) to provide the required data.

To successfully submit the report, obtain the template by selecting the Download Participant Level Data Template button on the Inclusion Enrollment Report screen (it is critical that you use this template for submission) and enter Individual-level participant data on sex or gender, race, ethnicity, and age at enrollment.

It is important that you do not alter the template; altering the format or category titles results in an error during the uploading process. Use only acceptable values for the inclusion variables are shown in the sample data on the template, and on the participant-level data tip sheet; using unacceptable values for the inclusion variables will also result in an error.

Some commons examples might be the use of ‘Latin American’ for ethnicity when ‘Hispanic or Latino’ is the only acceptable category value. Another example is age at the time of enrollment.  If the age of a participant is unknown, the value of zero or the word unknown is sometimes given.  In this case, the age value should be left blank and age category is ‘unknown.’

If you do encounter an error, read the error message carefully as it provides some tips to troubleshoot the issue.  To help you with troubleshooting those errors, check out the video How to Address Errors When Using the Participant Level Data Template.

Other resources available to you are:

One comment

  1. Hi, will this rule apply to network trials? that is where a data center used to provide aggregate data on enrollment.

Before submitting your comment, please review our blog comment policies.

Leave a Reply

Your email address will not be published. Required fields are marked *